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SoftSOAK

by Madhu Instruments Private Limited EUDAMED

Active European Union

Ref MIPL/B2/5Model PVA SPONGE SPEAR

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08906025961734 Basic UDI-DIDate22 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Specification

EUDAMED

Device Name
Fluid Management Device
Model / Reference
PVA SPONGE SPEAR, MIPL/B2/5
Primary DI / UDI-DI
08906025961734
Basic UDI-DI
B-08906025961734
EMDN Code
Q021199 Ophthalmic surgery instruments, single-use - other
Device Class
Class I
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IN-MF-000017447
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Madhu Instruments Private Limited

See all devices from Madhu Instruments Private Limited →

Properties

  • Sterile

Other properties (10)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No